Gold standard defence

Four years on, experts reflect on the ill-fated TGN 1412 drug trial and define a model of excellence for safe-guarding brands through a crisis

A basic lesson at journalism school is never use the word 'unique' as so few situations truly fit that bill. After years at the newspaper coalface, it proved to be right, as the same old stories came round, just with different players and scenarios.

But on one memorable occasion, when I was health editor of The Sun in 2006, the word was clearly justified. In the late afternoon, a distraught woman rang the health desk – very close to deadline – to tell us of a clinical trial that appeared to have gone disastrously wrong.

My team put in some calls and I did some research. The deputy editor pounded over. "How common is this," he asked, judging whether it was worth the front page. For the first time in my career, I answered that I had never come across anything like it.

By early evening, all the nationals were on to it. The following day, a BBC worker, Myfanwy Marshall, stood tearfully outside the hospital and proclaimed that her boyfriend, one of the affected men inside, looked like the 'Elephant Man'. That essential tabloid hook gave the story life and legs.

So how can companies manage a crisis like this and come out the other side, should 'the worst happen'? This special two-part feature analyses what happened at the time, and what lessons have been learned. This month, I talk to those involved, and next month, I reveal what independent crisis communications specialists would advise in a situation like this.

To recapTeGenero, a German company, had designed a drug called TGN 1412 to treat leukaemia and chronic inflammatory conditions. It used US company Parexel to run a phase 1 clinical trial at an independent unit in the grounds of Northwick Park Hospital in north London. On March 13, 2006, eight volunteers, including two on a placebo, were injected with the trial drug at intervals.

They had each been paid £2,000. By midnight, the six who had had the active drug had been transferred to the hospital's intensive care unit, suffering organ failure and swelling.

A rash of headlines followed, such as "We Saw Human Guinea Pigs Explode" in The Sun; later, some of the men sold their stories.

I felt sympathy for Mark Herbert, the hospital's head of communications. The Trust's intensive care specialists almost certainly saved the men's lives. But as they were all being treated at Northwick Park, he was inundated with calls. He had to repeat over and over that the trial was nothing to do with the Trust, but they still became synonymous. Even The Guardian, in a follow-up feature three years ago, called it the "catastrophic drug tests at Northwick Park Hospital". Mark did a good job in very difficult ircumstances.

After initially giving statements, Parexel became quieter, not responding to requests for extra information, preferring to use the internet to put out intermittent statements.

This kind of behaviour infuriates journalists and particularly tabloid newspaper executives. The Sun's US editor was asked to 'doorstep' Parexel's chief executive at his office and home. A spokesman told her that the CEO was too busy to talk to her. This led to an excoriating leader headed "Say Sorry".

So what happened next? Five victims remained in hospital for a month; Ryan Wilson, who suffered heart, liver and kidney failure, pneumonia, septicaemia and amputation of his toes, was there for four months.

A Medicines and Healthcare Products Regulatory Agency (MHRA) investigation concluded in May that Parexel was not to blame, and that "an unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions".

But controversy continued. In July, a report by a respected immunologist said that the triallists' life expectancy has been reduced; in the same month, TeGenero filed for insolvency. In September, a Channel 4 Dispatches programme claimed the speed at which the drug was given to participants was too fast. In December, Professor Gordon Duff issued 22 new guidelines for future phase 1 trials. A year after the drug trial, the Royal Statistical Society claimed it was poorly designed and possible risks had not been taken fully into account.

So what do the people involved in the story think, four years on, of the practical and strategic decisions taken and their impact? Disappointedly, but not unexpectedly, Parexel said: "We cannot provide information in this regard,” and declined to participate.

North West London Hospitals NHS Trust took a more open attitude. It admitted its reputation was affected, despite the heroic efforts of the press team at the time, and added that important lessons have been learned and acted on, such as the need to communicate effectively internally to prevent a decline in staff morale.

Fiona Wilde, acting director of communications, said: "It was difficult to get our two key messages across – that Parexel was a completely separate organisation that leased premises off the Trust, and that our staff had saved the lives of the six men who were involved in the trial.

"It is still a challenge for us to make journalists understand this, and even now there are still stories about the 'drugs trials at Northwick Park', though these are becoming fewer.

"Staff were very hurt by the media coverage and the damage the story did to our reputation, particularly when we had saved the lives of the men involved in the trial. So, internally, we have done a lot of work with our staff, including presentations by the clinicians involved, to explain our side of the story.

"Externally, we took – and continue to take – a proactive response if we feel we have been misrepresented in the media, such as writing letters to the editor. Our clinicians have taken part in several documentaries and have spoken nationally at conferences about the care they managed to provide in such extraordinary circumstances."

At the time, the hospital had to contend with dozens of journalists, photographers and cameras camped outside, but after the initial 48-hour burst of activity, with the patients stable, the story moved more slowly than the news media would have liked.

In the first few days, the Trust enabled two pooled interviews with print journalists and a TV camera at both with the director of the intensive care unit, but, after that, gave 12-hourly written updates at the hospital and on the website, so the doctors could concentrate on their patients.

In retrospect, Mr Herbert believes that more frequent TV updates by a senior doctor, either to a pooled camera or in an open press conference, would have created more opportunities to explain the distinction between the roles of Parexel and the Trust.

However, he said: "While this might have helped the long-term reputation of the hospital, naturally the top priority at the time was the patient care."

Another person on the receiving end of the journalists' demands was David Standard, then head of media relations for law firm Irwin Mitchell, which represented Ryan Wilson. The calls ran into months as the various reports were published.

Mr Standard, who is now director of marketing and business development with law firm Geldards, said: "The media attention was constant and huge. We kept up the pressure for answers and for measures to be put in place that would ensure it couldn't happen again."

Some of those involved at the time had a grudging respect for the way Parexel 'put up the shutters' and left it to others to comment. But Mr Standard felt that Parexel and TeGenero, while in a difficult position, should have been more open with the media.

He said: "It is very difficult for companies, as the pressures with a clinical trial are two-fold. There will always be a duty of medical confidentiality to the patient, which makes it difficult to say anything meaningful without the patient's consent. Secondly, a company will often be in the hands of its public liability insurers and it risks invalidating its cover if it makes any public admissions without prior agreement.

"There is no simple solution, however, an agreed statement of the facts providing an honest update on events that avoids confidentiality breaches and ensures non-accusatory or self-incriminating comments, is going to be far more respected by a media pack and, in turn, the public, desperate for the next 15-minute headline.

"If at all possible, the best strategy for the company is to attempt to have a discreet, open and caring dialogue with the patient, his family or, if necessary, his representatives. A speedy admission of responsibility, apology, explanation and genuine offer of help, support and, if appropriate, money, can sometimes defuse an explosive situation before it hits the media. The patient wants someone to accept responsibility, in a very human and genuine way, and say sorry."

Mr Herbert believes having a crisis plan is vital in limiting the damage. A former long-term Royal Mail communications manager, he left the hospital later in 2006 – in a pre-planned career move – to become director of communications at the British Council.

He said: "I had had crisis management training and had dealt with a fair few difficult stories at Royal Mail, but this was one of a different order. We were glad to have a crisis plan in place and this is perhaps the most important learning point.

Finally, in this image-led world, Mr Herbert made the point that simple visual cues are so important in crisis situations. "In the days after the trial, had there been a big 'Parexel' sign outside the hospital for TV reporters to stand in front of while filming, it might have been more obvious that it was Parexel who ran the trial and the NHS that was picking up the pieces."

Tips by those involved

1. Have a crisis plan in place and make sure that senior colleagues are aware of it2. Have access to the contact details of all senior colleagues available at all times3. Establish a small group to manage the crisis, with clear roles and good leadership. Meet frequently and establish a flow of information that the press office can use 4. Communicate to the media as fully and early as possible, ideally using a credible spokesperson in addition to written statements 5. Think about the overall message you need to get across to the media to help them do their job – and present it in a way that works for print, online, TV, radio6. Don't forget to tell your staff what is going on too. They will be talking to friends and family7. See/read how the media are running the story and be ready to correct inaccuracies quickly8. Keep other stakeholders within and outside your organisations informed so that they don't have to rely on the media.

In the March issue of Pharmaceutical Marketing, we talk to independent crisis communications specialists on their view of how the TGN 1412 drugs trial was handled. If you have comments, email jacqui@jacquithornton.com